Quality/ Regulatory Specialist, Medical Devices

Russell Taylor Group; Liverpool; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Quality/Regulatory Specialist to ensure compliance with ISO standards and regulatory requirements. The role involves working closely with the QARA team to manage quality systems, investigate complaints, and maintain product registrations. Ideal candidates will have a degree in Life Sciences and prior QA/RA experience within the IVD sector.

Benefits

Parking onsite

Private medical insurance

Life assurance

Company pension

Qualifications

• Minimum educated to Degree level in a Life Science subject.
• Previous QA/RA experience and understanding of QMS standards.
• Experience in the IVD/Diagnostics sector is ideal.

Responsibilities

• Maintain compliance with ISO standards and regulatory requirements.
• Investigate complaints and ensure corrective actions are taken.
• Oversee QMS activities including internal audits and document control.

Skills

ISO 13485

ISO 9001

ISO 17025

Report Writing

Communication

IT Proficiency

Education

Degree in Life Science

Job description

Quality/ Regulatory Specialist, Medical Devices

Vacancy Title: Quality/ Regulatory Specialist, Medical Devices

Vacancy Title: Quality/ Regulatory Specialist, Medical Devices Contract Type: Permanent Location: Liverpool Industry: SCIENTIFIC Salary: £30000 - £40000 per annum Start Date: 2025-06-17 REF: J91984150 Contact Name: Tom Hammond Contact Email: [e-mail] Vacancy Published: 1 day ago Quality/ Regulatory Specialist, Medical Devices

Based in Liverpool
Permanent
Monday - Friday 8:30am - 4.30pm
Competitive salary
Parking onsite, private medical, life assurance, company pension

Our Client, an established Medical Devices company / IVD are looking to recruit for an additional experienced QA/RA Officer to work at their modern R&D facility based on the outskirts of Liverpool. The role also includes additional duties across Regulatory Affairs in relation to Medical Device regulations.

Duties:

• Working closely with the QARA Manager and Team Leader, maintaining compliance with applicable ISO Quality standards (ISO13485 and ISO9001) and the regulatory and statutory requirements of the IVDR, necessary for the continued business activities of the Client.
• Investigation into complaints received, ensuring corrective action and preventive measures are identified, documented and actioned, in line with QMS requirements.
• Involvement in all other QMS requirements, including Internal audits, document control, Qualification and Validation projects, change control, Supplier approval, monitoring and re-evaluation
• Oversee and maintain portals for training records and equipment calibration records.
• Work with R&D staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements (IVDR / UKCA).
• Ensure Client products are registered in accordance with relevant national requirements for UK and also for Global use, as required.
• Provide advice/guidance to departments in regulatory matters.
• Create relevant paperwork required to support global shipment of manufactured product.
• Investigate and action ad-hoc global regulatory enquiries and provide necessary documentation.
• Preparation of written reports and documentation.
• In addition to the specified duties the Quality Assurance and Regulatory Affairs Specialist is expected to perform additional tasks that the company may require.


Qualification and Experience:

• Minimum educated to Degree level in a Life Science (Biomedical, Microbiology, Biotechnology, etc) subject.
• Previous QA/ RA experience
• A solid understanding of ISO 134845, 9001, 17025 standards and working to these QMS.
• The ideal applicant will have worked in the IVD/ Diagnostics sector.
• The ideal Candidate will have previous regulatory experience.
• Experience in raising non conformances, CAPAs etc
• Strong report writing skills, and communicative skills required.
• Will be IT proficient working across a range of software's and applications.



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